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| ID | Type | Description | Link |
|---|---|---|---|
| SCOUT-IIT | Other Identifier | HMH | |
| BED-IIT-479 | Other Grant/Funding Number | Funding Source |
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| Name | Class |
|---|---|
| Blue Earth Diagnostics | INDUSTRY |
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To evaluate the effectiveness of a PSMA-PET scan in identifying recurrent prostate cancer after focal therapy
PSMA is a protein that is highly expressed in prostate cancer cells, making it an excellent specific target for imaging with PET scans that can provide detailed information about the location, extent and aggressiveness of prostate cancer lesions. These scans have proven invaluable for identifying and characterizing prostate cancer, aiding in treatment planning, and Monitoring treatment response. It's true and fully utility in focal therapy for prostate cancer is unknown.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-rhPSMA-7.3 | Experimental | Patients will undergo a PSMA-PET scan at 1 year (+/- 60 days) after treatment with SOC focal therapy using a radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)-targeted PET scan using 18F-rhPSMA-7.3 (Posluma). The rhPSMA-targeted PET scan is an FDA-approved PET scan to detect the presence of lesions positive for prostate-specific membrane antigen (PSMA) in men with prostate cancer. 18F-rhPSMA-7.3 (Posluma) injection is a radioactive diagnostic agent that is administered in the form of an intravenous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-rhPSMA-7.3 | Drug | Utility of 18F-rhPSMA-7.3 in the diagnosis of prostate cancer after Focal Gland Treatment (SCOUT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effectiveness of PSMA-PET scan in identifying recurrent prostate cancer after focal therapy | All patients will get a biopsy to assess the effectiveness of treatment at 1 year, which is standard protocol at our institutions (all patients undergo biopsy at year 1 and 3 at our institutions). The post-treatment PSMA-PET scan will be correlated to 1-year biopsy results to study the utility of such a scan. Recurrence is defined by a positive PSMA-PET scan and positive biopsy in the area of PET scan tracer uptake at 1 year after SOC focal treatment. | Approximately 1 year after SOC focal therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| To report the sensitivity and specificity in evaluating PSMA-PET scan | Sensitivity and specificity will be reported under the ROC and AUC analysis. | Approximately 1 year after SOC focal therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oncology Clinical Research Referral Office | Contact | 551-996-1777 | OncologyResearchReferral@hmhn.org |
| Name | Affiliation | Role |
|---|---|---|
| Nitin Yerrman, MD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Theurer Cancer Center at Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33532112 | Background | Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available. | |
| 34489140 | Background | Hopstaken JS, Bomers JGR, Sedelaar MJP, Valerio M, Futterer JJ, Rovers MM. An Updated Systematic Review on Focal Therapy in Localized Prostate Cancer: What Has Changed over the Past 5 Years? Eur Urol. 2022 Jan;81(1):5-33. doi: 10.1016/j.eururo.2021.08.005. Epub 2021 Sep 4. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 27825428 | Background | Nguyen-Nielsen M, Borre M. Diagnostic and Therapeutic Strategies for Prostate Cancer. Semin Nucl Med. 2016 Nov;46(6):484-490. doi: 10.1053/j.semnuclmed.2016.07.002. Epub 2016 Sep 3. |
| 16985927 | Background | Chang SS. Overview of prostate-specific membrane antigen. Rev Urol. 2004;6 Suppl 10(Suppl 10):S13-8. |
| 37627956 | Background | Cereser L, Evangelista L, Giannarini G, Girometti R. Prostate MRI and PSMA-PET in the Primary Diagnosis of Prostate Cancer. Diagnostics (Basel). 2023 Aug 17;13(16):2697. doi: 10.3390/diagnostics13162697. |
| 36201182 | Background | Kwon DH, Velazquez AI, de Kouchkovsky I. PSMA PET Scan. JAMA Oncol. 2022 Dec 1;8(12):1860. doi: 10.1001/jamaoncol.2022.3531. |
| 31366128 | Background | Testa U, Castelli G, Pelosi E. Cellular and Molecular Mechanisms Underlying Prostate Cancer Development: Therapeutic Implications. Medicines (Basel). 2019 Jul 30;6(3):82. doi: 10.3390/medicines6030082. |
| 36633525 | Background | Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763. |
| 21056534 | Background | Heidenreich A, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Mottet N, Schmid HP, van der Kwast T, Wiegel T, Zattoni F; European Association of Urology. EAU guidelines on prostate cancer. Part 1: screening, diagnosis, and treatment of clinically localised disease. Eur Urol. 2011 Jan;59(1):61-71. doi: 10.1016/j.eururo.2010.10.039. Epub 2010 Oct 28. |
| 21801679 | Background | Izawa JI, Klotz L, Siemens DR, Kassouf W, So A, Jordan J, Chetner M, Iansavichene AE. Prostate cancer screening: Canadian guidelines 2011. Can Urol Assoc J. 2011 Aug;5(4):235-40. doi: 10.5489/cuaj.11134. No abstract available. |
| 30442734 | Background | Olleik G, Kassouf W, Aprikian A, Hu J, Vanhuyse M, Cury F, Peacock S, Bonnevier E, Palenius E, Dragomir A. Evaluation of New Tests and Interventions for Prostate Cancer Management: A Systematic Review. J Natl Compr Canc Netw. 2018 Nov;16(11):1340-1351. doi: 10.6004/jnccn.2018.7055. |
| 35136289 | Background | Atluri S, Mouzannar A, Venkatramani V, Parekh DJ, Nahar B. Focal therapy for localized prostate cancer - Current status. Indian J Urol. 2022 Jan-Mar;38(1):7-14. doi: 10.4103/iju.iju_166_21. Epub 2022 Jan 1. |
| 19050692 | Background | Borley N, Feneley MR. Prostate cancer: diagnosis and staging. Asian J Androl. 2009 Jan;11(1):74-80. doi: 10.1038/aja.2008.19. Epub 2008 Dec 1. |
| 33052837 | Background | Ortner G, Tzanaki E, Rai BP, Nagele U, Tokas T. Transperineal prostate biopsy: The modern gold standard to prostate cancer diagnosis. Turk J Urol. 2021 Feb;47(Supp. 1):S19-S26. doi: 10.5152/tud.2020.20358. Epub 2020 Oct 9. |
| 34911650 | Background | Moreira LF, Mussi TC, Cunha MLD, Filippi RZ, Baroni RH. Accuracy of 68Ga-PSMA PET/CT for lymph node and bone primary staging in prostate cancer. Urol Oncol. 2022 Mar;40(3):104.e17-104.e21. doi: 10.1016/j.urolonc.2021.11.007. Epub 2021 Dec 13. |
| 37444512 | Background | Hoffman A, Amiel GE. The Impact of PSMA PET/CT on Modern Prostate Cancer Management and Decision Making-The Urological Perspective. Cancers (Basel). 2023 Jun 29;15(13):3402. doi: 10.3390/cancers15133402. |
| Background | Lu, Grace, |
| 7063747 | Background | Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology. 1982 Apr;143(1):29-36. doi: 10.1148/radiology.143.1.7063747. |
| 28094848 | Background | Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17. |
| 35536144 | Background | Eastham JA, Auffenberg GB, Barocas DA, Chou R, Crispino T, Davis JW, Eggener S, Horwitz EM, Kane CJ, Kirkby E, Lin DW, McBride SM, Morgans AK, Pierorazio PM, Rodrigues G, Wong WW, Boorjian SA. Clinically Localized Prostate Cancer: AUA/ASTRO Guideline, Part I: Introduction, Risk Assessment, Staging, and Risk-Based Management. J Urol. 2022 Jul;208(1):10-18. doi: 10.1097/JU.0000000000002757. Epub 2022 May 10. |
| Background | National Comprehensive Cancer Network. Prostate Cancer (Version 4.2024). May 17, 2024]; Available from: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |